Fulgent reports Phase 2 FID-007 combo data: 51% ORR, PFS 7.8 months in R/M HNSCC

Fulgent Genetics, Inc.

Preliminary Phase 2 data for FID-007 + cetuximab in 1L-2L R/M HNSCC; 39 patients randomized.
Overall ORR 51% (75 mg/m2: 44%, 125 mg/m2: 59%); median PFS 7.8 months vs historical 2.3 months.
Treatment-related SAE rate 6%; no grade 3+ peripheral neuropathy; common grade 3+ events include lymphopenia (19%) and neutropenia (17%).
Data presented at ESMO 2025 on October 20; optimal dose to be determined after data maturation.
CEO Ming Hsieh cites steady advancement of FID-007 and strong momentum in precision diagnostics.

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